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Cholesterol Lowering in Intermediate-Risk Persons

N Engl J Med; ePub 2016 Apr 2; Yusuf, Bosch, et al

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There was a significantly lower risk of cardiovascular events among an intermediate-risk, ethnically diverse patient population without cardiovascular disease when treated with rosuvastatin at a dose of 10 mg per day when compared to placebo. This according to a study of 12,705 participants who did not have cardiovascular disease and who were randomly assigned to receive rosuvastatin at a dose of 10 mg per day or placebo. Researchers found:

• The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group.

• The first coprimary outcome, the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (HR=0.76).

• The results for the second coprimary outcome, additionally included revascularization, heart failure, and resuscitated cardiac arrest, were consistent with the results from the first.

• The results were also consistent in subgroups defined according to CV risk as baseline, lipid level, C-reactive protein level, blood pressure, and race of ethic group.

• In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery and muscle symptoms.

Citation: Yusuf S, Bosch J, Dagenais G, et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. [Published online ahead of print April 2, 2016]. N Engl J Med. doi:10.1056/NEJMoa1600176.

Commentary: This study was remarkable in that it looked at an intermediate-risk group with essentially normal LDL-cholesterol levels, and used risk, not LDL level, as the criteria for entry into the study. Eligibility criteria included men aged >55 years and women aged >65 years who had at least 1 of the following risk factors: elevated waist-to-hip ratio, history of a low level of high-density lipoprotein cholesterol, current or recent tobacco use, dysglycemia, family history of premature coronary disease, and mild renal dysfunction. Women aged >60 with 2 of the risk factors were also eligible. Patients were excluded from the study if they had existent cardiovascular disease or essentially if statins where otherwise indicated. Average LDL level at the start of the study was 127 mg/dl. The study showed approximately a 25% decrease in the incidence of major CV events, with a minor increase in side effects in the treatment group. The results of this study are consistent with the results of the JUPITER trial, where patients who had normal LDL and HDL cholesterol (average LDL-128, HDL-49) and elevated CRP had a decrease of 44% in cardiovascular outcomes on rosuvastatin 20 mg daily.1 The current study supports that statins, regardless of baseline LDL, are effective in the primary prevention of cardiovascular disease in patients at intermediate cardiovascular risk. —Neil Skolnik, MD

1. Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008; 359:2195-207. doi:10.1056/NEJMoa0807646.

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